Safety of Catheter Lock With or Without Heparin in Implanted Central Venous Catheters

Phase 4

Completed

• Conditions: Hematologic Disease; Oncology, Medical
• Interventions: Drug: normal saline

• Registration Number: NCT00994136
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

Long-term central venous access devices are considered as safe for the administration of medication as chemotherapy, but are also used for blood sampling. For years these catheters have been locked with a heparin solution in order to avoid occlusion. However, no scientific evidence supports heparin locking when the device is not in use. Advanced technology as needleless caps and valved catheters and port reservoirs confirms this trend to use 'saline only' for locking these devices. Therefore the investigators hypothesize is that there will be no difference in proportion of occlusions and catheter related bacteremia in long-term venous access devices locked with 'saline only' versus with heparin.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-10-13
• Study First Submitted QC: 2009-10-13
• Study First Posted: 2009-10-14
• Status Verified: 2011-06
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Last Update Submitted: 2011-06-08
• Last Update Posted: 2011-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1100

Inclusion Criteria

• Oncology and hematology patients
• Life expectancy of minimum of 180 days

Exclusion Criteria

• second or femoral long-term central venous access device
• known allergy to heparin (HIT)
• coagulation disorders(INR >2, Blood platelets > 1,000,000/mm3)
• therapeutic intravenous heparin administration

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal saline	normal saline	In the intervention group the use of heparin as locking solution in the catheter lumen (or lumina) when the catheter is not longer in use is omitted. Catheters are locked under positive pressure with normal saline in stead injecting an extra volume of heparinised saline (100IU/ml).
Heparin lock	normal saline	-

Primary Outcome Measures

Name	Time	Method
Withdrawal occlusion	within180 days

Secondary Outcome Measures

Name	Time	Method
all catheter-related bacteremia	within 180 days
Incidence of functional problems other than withdrawal occlusion	within 180 days

Trial Locations

Locations (1)

Universitaire Ziekenhuizen Leuven; 🇧🇪 Leuven, Vlaams-Brabant, Belgium